Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer

Prostate Cancer Clinical Trial

Official title:

A Study to Assess if a Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773773
• Other study ID #: 08-114
• Status: Completed
• Phase: N/A
• Start date: October 14, 2008
• Est. completion date: March 8, 2024

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, serum proteomics study of men who are to undergo prostate biopsy. The purpose is to determine if proteomic profiles can be used to distinguish between men with prostate cancer on biopsy from men with no cancer on biopsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 8, 2024
• Est. primary completion date: March 8, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men aged 18 years or older

• Have a PSA level between 2 and 10 ng/ml

• May or may not have an abnormal digital rectal examination

• Scheduled for trans-rectal ultrasound (TRUS) guided systematic prostate biopsy as part of routine medical care. All sites (Department of Urology at SUNY Downstate Medical Center, Brooklyn, the Department of Urology, New York Presbyterian Hospital, Weill Medical College of Cornell University, Manhattan and the Department of Urology, Kings County Hospital) will perform a standardized 14 core biopsy protocol.

• Signed, informed consent

• Patient must be able to attend the pre-biopsy blood draw

Exclusion Criteria:

• Any period of prior/current treatment with hormonal therapy (LHRH agonist/antagonist,antiandrogen, 5-alpha-reductase inhibitor)

• Prior pelvic radiation

• A period of less than 6 months prior/current treatment with an alpha-blocker

• Previous diagnosis of prostate cancer

Related Conditions & MeSH terms

• Elevated Prostate Specific Antigen (PSA)
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.
Patients referred for prostate biopsy as part of their routine care are to be recruited. Patients will undergo standard medical evaluation/care by undergoing a prostate biopsy because of an elevated PSA blood test and/or an abnormal digital rectal prostate examination. The protocol involves obtaining the research blood sample at the time of routine pre-biopsy blood draw. As such, an extra five (40 mL) tubes of blood will be drawn. The serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.

Locations

Country	Name	City	State
United States	Kings County Hopsital Center	Brooklyn	New York
United States	SUNY Downstate Medical Center (DMC)	Brooklyn	New York
United States	Memorial Sloan Kettering Cancer Center (All protocol activites)	New York	New York
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (7)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Kings County Hospital, National Institutes of Health (NIH), New York Presbyterian Hospital, NYU Langone Health, State University of New York - Downstate Medical Center, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if men with prostate cancer have a different proteomic profile than men without cancer. Cancer-free status will be confirmed by a re-biopsy at 6 months to reduce the biopsy false negative rate to less than 5 %.		conclusion of study
Primary	To determine whether the peptide proteomic profile can improve the predictive ability of known serum biomarkers (PSA (free and total), hK2 and su-PAR) for prostate cancer.		conclusion of the study
Secondary	To determine if Caucasian men and men of African-American descent with and without prostate cancer have different proteomic profiles.		conclusion of the study
Secondary	To assess reproducibility of proteomic profiles over different runs, platforms, and sites.		conclusion of the study
Secondary	To procure a DNA repository from these patients undergoing prostate biopsy for future assessment of kallikrein gene expression.		conclusion of the study
Secondary	To establish a bank of DNA, serum, and frozen lymphoblastoid cells from these patients for the purpose of enabling genetic investigations in men with a diagnosis of prostate cancer.		conclusion of the study

External Links

•   Memorial Sloan-Kettering Cancer Center